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This problem has resulted in the deaths of 23 people and 60 injuries.
The FDA has designated this as an Class I Recall, which is the most serious kind. https://www.fcc.gov/fcc-bin/bye?https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause These devices could cause serious injury or even death.
Sam Brusco Associates Editor05.16.22
The FDA has confirmed Avanos Medical’s recall for its Cortrak*2 oral access device. http://www.drugoffice.gov.hk/gb/unigb/www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ Beginning on March 21 the 21st of March, 2016, 629 devices were recalled across the U.S.
Cortrak*2 assists clinicians in placing medical feeding tubes into the stomachs or small bowels of patients that need to be fed by the tube.
Avanos Medical feeding tube https://farangmart.co.th/author/avanos-medical-feeding-tubezqcx732/ Due to injuries and deaths due to injuries and deaths, the system was recall. A mistake in the placement of a Nasogastric or Nasoenteric tube could cause severe injury or death.
According to Avanos' safety communication There have been sixty-three injuries and 23 deaths in connection with this incident. The adverse events that were reported include respiratory failure, pneumothorax, perforation, pneumonia and the development of pleural effusion.
Cortrak*2 will use the recall process to modify its directions for usage and intended use. Avanos Medical feeding tube It will also instruct users to ensure the tube is placed using institutional protocols before delivering nutritional supplements.
Clinicians are also advised to attach the field correction note to the operating manual , and return the acknowledgement form included in the notice to Avanos. http://ezproxy.cityu.edu.hk/login?url=https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ The company plans to provide users with current labeling, as well as confirmation of tube placement in accordance to institutional policies.
Read More: http://www.drugoffice.gov.hk/gb/unigb/www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/
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